RadProtect for Radiation Protection

Overseen By San Tseng

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Original BioMedicals Co. Ltd.

Must not be taking: Hormone replacement therapy

Disqualifiers: Diabetes, Hypertension, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

27 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the RadProtect trial?

The trial protocol does not specify if you must stop taking your current medications, but you must agree to abstain from taking unauthorized medications or supplements during the trial.

What data supports the effectiveness of the drug RadProtect® for radiation protection?

Research shows that combining radioprotective agents can be more effective than using them individually, suggesting that RadProtect® might work well when used with other treatments. Additionally, radioprotectors can help protect normal tissues from radiation damage, potentially improving outcomes in cancer treatment. ^{1 2 3 4 5}

How does the RadProtect treatment differ from other radiation protection treatments?

RadProtect is unique because it is designed to protect against radiation injury when given before exposure, allowing for higher radiation doses in cancer treatment with less damage to normal tissues. This makes it different from other treatments that may only mitigate damage after exposure. ^{1 6 7 8 9}

What is the purpose of this trial?

This trial tests RadProtect® in healthy volunteers to ensure it is safe and well-tolerated. The main goal is to observe side effects and determine safe dosage levels.

Eligibility Criteria

Healthy adults aged 18-64 with normal blood pressure and BMI of 18-30 kg/m^2 can join. They must not have diabetes, heart, liver, or kidney diseases, active cancer, or certain other conditions. Participants need to use reliable contraception and avoid other trials or experimental treatments.

Inclusion Criteria

Subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial.

I am using effective birth control and will continue for 60 days after the trial.

My BMI is between 18 and 30.

Exclusion Criteria

You drink more than five alcoholic beverages every week.

Subjects who are pregnant or lactating

I am allergic to glutamate acid, polyethylene glycol, or ingredients in the test medicine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RadProtect® intravenous injection and are monitored for safety and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including dose limiting toxicity and pharmacokinetic analysis

28 days

3 telephone visits on Day 3, Day 14+2, and Day 28+2

Treatment Details

Interventions

• RadProtect®

Trial Overview The trial is testing RadProtect®, a new drug for preventing radiation injury. It's an early-stage study where volunteers receive increasing doses to check the drug's safety and how it moves through the body over time.

Participant Groups

Group I: RadProtect® Experimental Treatment 1 Intervention

RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine. Transferrin and other related proteins can chelate with ferrous iron and break the micelle releasing amifostine into the blood stream.

Who Is Running the Clinical Trial?

Original BioMedicals Co. Ltd.

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

In a study involving 137 patients undergoing coronary angiography and percutaneous coronary intervention, the use of RADPAD significantly reduced radiation exposure for the primary operator (PO) compared to procedures without it, with reductions in dose relative to various measures (CAST, DAP, and AK).

The findings also indicated that secondary operators (SO) experienced similar reductions in radiation exposure when RADPAD was used, highlighting its effectiveness in enhancing safety during fluoroscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing scattered radiation dose in cardiac catheterization laboratory during interventional procedures using lead free drape - MILD study. Bhat, KG., Guleria, VS., Singla, M., et al.[2022]

The RADPAD surgical drape significantly reduces radiation exposure to primary operators during routine diagnostic coronary angiography, with a 59% reduction in total radiation exposure and a 47% reduction in the radiation exposure rate.

In a study involving 60 patients, the primary operator's radiation dose was significantly lower when using the RADPAD (8.0 µSv) compared to the control group (19.6 µSv), indicating its efficacy in protecting healthcare staff from ionizing radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protective drape during coronary angiography. Kherad, B., Jerichow, T., Blaschke, F., et al.[2019]

In a randomized study of 60 patients undergoing coronary angiography, the use of the Radpad radiation shield significantly reduced the operator's radiation exposure by 23%, despite similar procedure times and total examination doses.

The Radpad shield provided consistent reductions in radiation exposure across various body locations, ranging from 13% to 34%, highlighting its effectiveness in protecting healthcare workers during interventional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. Politi, L., Biondi-Zoccai, G., Nocetti, L., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

New approaches to radiation protection. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Radioprotectors and mitigators of radiation-induced normal tissue injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Radioprotectants: adding quality of life to survivorship? [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Combining Pharmacological Countermeasures to Attenuate the Acute Radiation Syndrome-A Concise Review. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term Consequences of Pelvic Irradiation: Toxicities, Challenges, and Therapeutic Opportunities with Pharmacologic Mitigators. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Minimizing scattered radiation dose in cardiac catheterization laboratory during interventional procedures using lead free drape - MILD study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of RADPAD protective drape during coronary angiography. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Reduction of scatter radiation during transradial percutaneous coronary angiography: a randomized trial using a lead-free radiation shield. [2022]